A Randomized, Double-Blind, Multicenter, Parallel-Group Comparative Phase III Study Evaluating the Efficacy and Safety of TAK-816 Compared With ActHIB in Healthy Infants.
Phase of Trial: Phase III
Latest Information Update: 21 May 2016
At a glance
- Drugs TAK 816 (Primary) ; Diphtheria tetanus and pertussis vaccine; Hib vaccine conjugate
- Indications Diphtheria; Haemophilus infections; Pertussis; Tetanus
- Focus Pharmacodynamics; Registrational
- Sponsors Takeda
- 22 Jan 2016 According to Takeda media release, the Japanese Ministry of Health, Labour and Welfare has approved the New Drug Application ("NDA") for a conjugate vaccine to prevent infections caused by Haemophilus influenzae type b (Hib) in children aged from 2 months to under 5 years of age.
- 26 Sep 2013 An NDA was submitted in Japan for TAK-816 for prevention of invasive Hib disease in children based on positive results from this trial, according to a Takeda media release.
- 01 Feb 2013 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.